Human Subjects Research: Policies, Inclusion, & Clinical Trials – Free 2-Day Virtual Event with NIH & HHS Experts – December 6-7, 2022

 

  • What are the basic HHS regulations and NIH policies that apply to research involving human subjects, including clinical trials?
  • How do you prepare a research application or proposal for review that addresses the regulatory requirements?
  • What are some strategies for developing realistic and scientifically acceptable inclusion plans?

Join experts from the NIH Division of Human Subjects Research and the HHS Office of Human Research Protections (OHRP) for answers to these questions and so much more! During this 2-day, informative and engaging event, you’ll receive the latest updates, resources, and guidance related to human subjects research, as well as the opportunity to test your knowledge in case studies. Opportunities to ask questions during the live Q&A are available after each presentation topic. Don’t miss out!

2-Day Event: Tuesday, December 6 - Wednesday, December 7, 2022

Time: 12:00 – 4:00 PM ET Daily

Agenda Topics: (See Agenda Details with Presenter Bios)

Day 1 (December 6) Topics:

  • How Do I Know if a Research Study is Human Subjects Research and What Does that Really Mean?
  • What You Need to Know about FWAs and IRBs to Get Your Grant Money
  • An Overview of NIH Policies on Human Subjects
  • Essentials of sIRB Requirements

Day 2 (December 7) Topics:

  • An Overview of NIH Policies on Clinical Trials
  • Including Diverse Populations in NIH Clinical Research
  • Using the eRA Human Subjects System (HSS)
  • Extended Q&A with Human Subjects Expert Panel (HHS and NIH)

ONE REGISTRATION. ALL-ACCESS. NO COST.

Registration is free and provides you with an “All Access Pass” to the virtual NIH Grants Conference 2022-2023 season … including this 2-day event in December, past monthly event recordings and PPTs, the 2-day conference in February, and a multitude of valuable resources.

  • Once registered, log in to the NIH Grants Conference Center and explore the 3D platform.
  • Plan your experience by building your own agenda from the PreCon Events, Conference sessions, and on-demand videos listings.
  • Visit the NIH institute and program informational booths in the virtual Exhibit Hall at any time to view and download resources. Many of the 45 NIH booths will be staffed during the 2-day NIH Grants Conference in February 2023.

Monthly PreConference Events: This webinar is one of several monthly pre-conference events during the virtual NIH Grants Conference 2022-2023 season. Each “PreCon Event” provides an opportunity to take a deep dive into topics of interest to the NIH grants community.

  • Other Upcoming PreCon Events:
    • 2-Day Conference, February 1-2, 2023

 

 

NASA STUDENT FUNDING OPPORTUNITY

 

  • NASA’s Human Research Program (HRP) is requesting proposals for short-term investigations or technology development projects that augment existing HRP-funded tasks. Results of these one-year investigations are anticipated to deliver new tools, techniques, or knowledge that could lead to novel breakthroughs addressing one or more of the risks or gaps in the Human Research Roadmap (HRR). These short-term investigations may also provide initial results testing a new scientific approach, or they may provide the initial proof-of-concept for a new technology or method that has not yet been proven to address a risk or gap in the HRR. It is required that the proposer to this competition be a student (undergraduate or graduate) or postdoc working for a PI with an active HRP-funded project. This includes projects that are currently approved for no-cost extensions by HRP. This competition is not open to projects funded by TRISH, Space Biology, or other funding entities. Interested students or postdocs should submit a two-page proposal describing a research or technology idea that augments an existing HRP project from their own lab by 11:59 pm Central on December 11, 2022. The proposed research or technology must address one or more risks or gaps to human health and performance in space as outlined in the HRR (https://humanresearchroadmap.nasa.gov/). Required elements of the proposal include a title of the active HRP-funded project and name of funded PI, clear description of the research product(s), type of investigation (ground-based or analog definition), specific aims, outline of the plan to accomplish the specific aims, and a budget. The two-page proposal should be submitted via email to js-hrp-chief-science-office@mail.nasa.gov. Proposers should not duplicate ongoing efforts in their PI’s project. Awards will have a maximum value of $25,000 for one year and will be announced February 2023.

 

 

 

TRAINING

 

  • Virtual Micro Radiation Emergency Medicine (MicroREM). This virtual course is an abridged version of REAC/TS’ Radiation Emergency Medicine (REM) class. It focuses on the fundamentals of medical care and management of patients involved in radiological or nuclear incidents. Topics include basic radiation physics; radiation detection / measurement / identification; early evaluation and treatment of acute radiation syndrome (ARS), cutaneous injuries, and internal contamination; prehospital and hospital readiness; and patient decontamination. The microREM course will consist of three consecutive days of four-hour blocks of instruction. At a later date, an optional hands-on workshop will be offered with morning or afternoon sessions in Oak Ridge, Tennessee, where the principles learned are incorporated in a culminating hands-on exercise using live patients with mock injuries and transferable radioactive contamination. Registration is now available for the December 6-8, 2022 course (9:00 am – 1:00 pm EST; Fee is $200.00).  More details and other upcoming dates can be found here.   

  

 

NIH NEWS OF NOTE

 

  • NOT-OD-23-011  NIH Offers Ability to Bypass Two-Business Day Application Viewing Window as an Option for Administrative Supplements. Institutional signing officials now have the option to bypass the application viewing window for administrative supplement applications via the new ‘Verify’ action in eRA Commons Status, which moves an administrative supplement application forward for agency processing without waiting for the standard two-day application viewing window to expire.
  • NOT-OD-23-012  Reminder: FORMS-H Grant Application Forms & Instructions Must be Used for Due Dates on or After January 25, 2023 – New Grant Application Instructions Now Available. Applicants must use FORMS-H application packages for due dates on or after January 25, 2022. Instructions and significant changes to form instructions are available for applicant reference. 

 

 

CMCRC Annual Meeting (Hybrid)

 

 

Date: January 10-11, 2023

Venue: UMSOM BioPark

[801 W Baltimore St, Baltimore, MD 21201]

 

 

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Click on the link below and sign in with your CMCRC website user account to learn more about the meeting: https://cmcrcniaid.org/node/101

 

If you need a user account, please contact Ling Tang (litang@som.umaryland.edu).

 

 

FUNDING OPPORTUNITIES

 

NCI Pathway to Independence Award for Outstanding Early-Stage Postdoctoral Researchers (K99/R00 - Independent Clinical Trial Not Allowed). (RFA-CA-22-035) National Cancer Institute. The purpose of the NCI Pathway to Independence Award for Outstanding Early-Stage Postdoctoral Researchers (K99/R00) program is to increase and maintain a strong cohort of new and talented, NCI-supported, independent investigators. This program is designed for postdoctoral fellows with research and/or clinical doctoral degrees who do not require an extended period of mentored research training beyond their doctoral degrees. The objective of this award is to facilitate a timely transition of these fellows from their mentored, postdoctoral research positions to independent tenure-track (or equivalent) faculty positions. The program will provide independent NCI research support during this transition to help awardees to launch competitive, independent research careers. Researchers in the scientific areas of data science and cancer control science are especially encouraged to work with their institutions to apply. Application Receipt Date(s): February 28, 2023.

 

NIAID Research Opportunities for New and "At-Risk" Investigators to Promote Workforce Diversity (R01 Clinical Trial Optional). The purpose of this funding opportunity announcement is to encourage applications for research projects within the NIAID mission. This FOA seeks to support either (a) a New Investigator (NI), an individual who has not previously competed successfully for substantial, independent funding from NIH, or (b) are an 'At-Risk' investigator, an individual who had prior support as a PD/PI on a substantial independent research award and unless successful in securing a substantial research grant award in the current fiscal year, will have no substantial research grant funding in the following fiscal year, from diverse backgrounds, including those from groups underrepresented in the health-related sciences.

 

Notice of Special Interest (NOSI): Administrative Supplements to Recognize Excellence in Diversity, Equity, Inclusion, and Accessibility (DEIA) Mentorship. Participating Institutes and Centers (ICs, including NIAID) are inviting applications to support administrative supplements to existing NIH awards to support scientists who have demonstrated compelling commitments and contributions to mentorship and enhancing diversity, equity, inclusion, and accessibility (DEIA) in the biomedical sciences. Funds will support ongoing and future efforts.

 

RepAIR” Repurposing and Advancing Innovation against Rad/Nuc Threats. The BARDA Rad/Nuc branch has launched a new area of interest focusing on repurposing FDA approved drugs or those in late stage of development (past Phase 2) as potential ARS countermeasures. Strengthening the ability to respond to physical threats is a critical part of BARDA's strategy. Exposure to substantial doses of ionizing radiation, causes widespread cell death and leads to a spectrum of injuries across multiple organs, also known as Acute Radiation Syndrome (ARS). Due to the systemic multi-organ pathologies of ARS, fast-acting, effective medical countermeasures (MCM) are needed. With the Repurposing and Advancing Innovations Against Rad/Nuc (RePAIR) program, DRIVe and BARDA's Chemical, Biological, and Nuclear (CBRN) Division aim to support the testing and evaluation of repurposed drugs that have potential efficacy against ARS.

 

 

UPCOMING EVENTS

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International Society of Radiation Epidemiology and Dosimetry. 

 

Hybrid meeting to be held May 16-18, 2023. The objectives of the meeting are to allow radiation researchers – engaged in research related to epidemiology, biology, and dosimetry – to discuss results of recent and ongoing studies of radiation effects in humans; to provide training opportunities for the next generation of radiation researchers; and to promote international collaborations in radiation research. Register here!

 

 

RECENT PUBLICATIONS

 

Publication: “Hematopoietic Stem Cell Identification Postirradiation”

Drs. Andrea Patterson, Christie Orschell, and Louis Pelus outline techniques for hematopoietic stem cells (HSC) identification and analysis from mouse bone marrow postirradiation. [Methods Mol Biol. 2023;2567:127-140]

Andrea M. Patterson, Christie M. Orschell & Louis M. Pelus

Read more:  "Hematopoietic Stem Cell Identification Postirradiation”

 

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